FDA UDI
In Commercial Distribution
🇺🇸 United States
The Harris Products Group
DI: 00850005066552
·
Model: REG,301-50P BARE OXY
·
J. W. HARRIS CO., INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- The Harris Products Group
- Primary DI
- 00850005066552
- Version / Model
- REG,301-50P BARE OXY
- Catalog Number
- 3500751
- Company Name
- J. W. HARRIS CO., INC.
- Labeler DUNS
- 004233490
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-01-27
- Public Version
- 1
- Public Version Date
- 2022-02-04
- Public Version Status
- New
- Public Device Record Key
- 770401e3-21f9-4f51-b993-c3774578cc73
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CAN | Regulator, Pressure, Gas Cylinder | Anesthesiology | 868.2700 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12861 | Laboratory instrument gas monitor/regulator | A mains electricity (AC-powered) device designed to continuously measure and control the concentration of a gas(es) [e.g., oxygen (O2), carbon dioxide (CO2)] in an enclosed atmosphere, mainly in laboratory equipment (e.g., cell culture incubators, plate readers, imaging devices). It is an electronic unit which includes a gas percentage display, valves, gas sensors, controls, ports for connection to gas cylinders, and alarms triggered by out-of-range gas concentrations. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850005066552 | GS1 |